BS EN ISO 11137-2:2015

Foreword
Introduction
1 Scope
2 Normative references
3 Terms, definitions, and abbreviated terms
4 Definition and maintenance of product families
   for dose setting, dose substantiation, and sterilization
   dose auditing
5 Selection and testing of product for establishing
   the sterilization dose
6 Methods of dose establishment
7 Method 1: dose setting using bioburden information
8 Method 2: Dose setting using fraction positive
   information from incremental dosing to
   determine an extrapolation factor
9 Method VD[max] - Substantiation of 25 kGy or
   15 kGy as the sterilization dose
10 Sterilization dose audit
11 Worked examples
Annex ZA (informative) - Relationship between
         this European Standard and the Essential
         Requirements of EU Directive 90/385/EEC
         on active implantable medical devices
Annex ZB (informative) - Relationship between
         this European Standard and the Essential
         Requirements of EU Directive 93/42/EEC
         on medical devices
Annex ZC (informative) - Relationship between
         this European Standard and the Essential
         Requirements of EU Directive 98/79/EC
         on in vitro diagnostic medical devices
Bibliography

Describes methods for determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level, SAL, of 10[-6].

This part of ISO 11137 specifies methods for determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level, SAL, of 10⁻⁶. This part of ISO 11137 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose.

This part of ISO 11137 defines product families for sterilization dose establishment and sterilization dose audit.